Safety pharmacology of acute MDMA administration in healthy subjects
Patrick Vizeli, Matthias E. Liechti
Journal of Psychopharmacology February 21, 2017 DOI: 10.1177/0269881117691569 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Double-blind, placebo-controlled, crossover study Peer reviewed |
|---|---|
| Sample size | 166 |
| Population | Healthy subjects |
| Intervention | MDMA |
| Dose | 75 or 125 mg |
| Duration | Single-dose administration; follow-up at 29 ± 22 days |
| Topics | MDMA |
| Keywords | Adverse effect Placebo Heart rate Anesthesia Drug Tachycardia Blood pressure Pharmacology |
| Citations | 142 |
| Key points | MDMA at 75 or 125 mg was overall safe in healthy subjects in a medical setting, but produced dose-dependent increases in blood pressure, heart rate, and body temperature, with greater adverse effects in women. |
Abstract
3,4-Methylenedioxymethamphetamine (MDMA; ecstasy) is being investigated in MDMA-assisted psychotherapy. The present study characterized the safety pharmacology of single-dose administrations of MDMA (75 or 125 mg) using data from nine double-blind, placebo-controlled, crossover studies performed in the same laboratory in a total of 166 healthy subjects. The duration of the subjective effects was 4.2 ± 1.3 h (range: 1.4–8.2 h). The 125 mg dose of MDMA produced greater ‘good drug effect’ ratings than 75 mg. MDMA produced moderate and transient ‘bad drug effect’ ratings, which were greater in women than in men. MDMA increased systolic blood pressure to >160 mmHg, heart rate >100 beats/min, and body temperature >38°C in 33%, 29% and 19% of the subjects, respectively. These proportions of subjects with hypertension (>160 mmHg), tachycardia, and body temperature >38°C were all significantly greater after 125 mg MDMA compared with the 75 mg dose. Acute and subacute adverse effects of MDMA as assessed by the List of Complaints were dose-dependent and more frequent in females. MDMA did not affect liver or kidney function at EOS 29 ± 22 days after use. No serious adverse events occurred. In conclusion, MDMA produced predominantly acute positive subjective drug effects. Bad subjective drug effects and other adverse effects were significantly more common in women. MDMA administration was overall safe in physically and psychiatrically healthy subjects and in a medical setting. However, the risks of MDMA are likely higher in patients with cardiovascular disease and remain to be investigated in patients with psychiatric disorders.
Comparable studies
Other randomized controlled trials on MDMA, most cited first.
Citations in the library
Cited by 118
- MDMA-assisted therapy for severe PTSD: a randomized, double-blind, placebo-controlled phase 3 study. Nature Medicine June 1, 2021
- MDMA-assisted therapy for moderate to severe PTSD: a randomized, placebo-controlled phase 3 trial. Nature Medicine October 1, 2023
- Reduction in social anxiety after MDMA-assisted psychotherapy with autistic adults: a randomized, double-blind, placebo-controlled pilot study. Psychopharmacology November 1, 2018
- Designer drugs: mechanism of action and adverse effects Archives of Toxicology April 1, 2020
- Distinct acute effects of LSD, MDMA, and d-amphetamine in healthy subjects Neuropsychopharmacology November 16, 2019
and 113 more in the library
Cites 62
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and 57 more in the library